Not Applicable
Not Applicable
1. Field of the Invention
The present invention relates to a method and device for organizing, storing, and coordinating the combined use of liquid medications for continuous inhalation which are delivered by a nebulizer device for the treatment of respiratory tract disorders for the purposes of simplification, convenience, reducing medication error and increasing therapeutic compliance.
2. Description of the Related Art
Many drugs are utilized by patients over a period of time in varying amounts and in varying order to provide for their effective administration. Packaging has been developed for aiding the user of such drugs to comply with their proper administration over the proper time period. The dispensing apparatus associated with such multiple-day administrative drugs are typically directed to the administration of pills, capsules, or similar solid medication.
U.S. Pat. No. 4,039,080, for example, discloses a tray having individual compartments for pills which may contain a week""s medication with indicia indicating the day of the week and time of the day the medication is to be taken. U.S. Pat. No. 4,553,670 discloses another device comprising a support on which are located two different ingestible medicinal substances in a single-dose form with an adjacent portion for instructional information. U.S. Pat. No. 4,593,819 discloses a covered pill tray of rectangular configuration having an array of open-topped compartments to hold a supply of medication arranged by the day and time of taking the medication. U.S. Pat. No. 4,736,849 discloses a method and another type of dispenser for the storage and dispensing of calendar-oriented pills. U.S. Pat. No. 5,181,189 discloses a device for storage and time-regulated dispensing of drugs which includes a drug container to which is secured a signal generator. U.S. Pat. No. 5,377,841 discloses a sleep therapy package which includes an audio recording of program material for inducing sleep, a card having a plurality of doses, some of which are medicine for inducing sleep and at least one of which is placebo, along with patient instructions. U.S. Pat. No. 5,830,490, discloses a method and device for organizing and coordinating topical aerosols together with oral medications for treating respiratory disorders.
While the marketplace abounds with pill boxes and organizers for oral medications, and while a device to organize multi-dosage aerosol units and oral medications has been disclosed, no organizational tool is presently available for a lay person to organize medications which are provided to the user in liquid form for administration by continuous nebulization.
Because the respiratory tract is structured as a conduit for air, it is possible to deliver medication to the respiratory tract topically by aerosol to treat respiratory tract disorders. This may be accomplished with hand-held metered dose devices that deliver a single bolus of aerosol. The aerosol can be derived from liquid medication released from a pressurized canister (for example, Serevent(copyright) Inhalational Aerosol), or solid powdered medication particles which are dispersed in a chamber and deliberately inhaled (for example, Serevent Discus(copyright)). Alternatively, medication can be delivered to the respiratory tract by continuous nebulization of a liquid medication by a venturi type nebulizer or ultrasonic nebulizer as are well-known in the art. Continuous nebulization, typically over a period of minutes, is preferred, particularly for individuals who are unable to coordinate their inhalational effort or who are otherwise unable to master the technique of using hand-held metered dose inhalers, for example, infants, young children, and debilitated individuals. If continuous nebulization is desired, the user is required to employ a nebulizable medicinal liquid supplied in its own container and dispense the prescribed amount of the medication into the nebulization device for nebulization. Such containers are non-pressurized so as to allow them to be opened by a user and thereby convey the contents to the nebulization device. This is in contrast to the pressurized containers of metered dose inhalers that are often employed for treating respiratory disorders. The medicinal liquids for continuous nebulization are obligatorily packaged in non-pressurized containers. Examples of such non-pressurized containers include single-dose vials or a multiple-dose bottle with calibrated dropper.
Examples of such medicinal nebulizer liquids currently employed for continuous nebulization treatment of respiratory disorders include: Ventolin Nebules(copyright) marketed by Glaxo-Wellcome consisting of an inhalational solution of albuterol sulfate, 0.083% and packaged as 2.5 mg in a 3 ml plastic vial with a twist-off top, Proventil albuterol sulfate inhalational solution marketed by Schering consisting of albuterol 0.5% and supplied in a 20 ml amber bottle with a calibrated dropper, cromolyn sodium inhalational solution, USP marketed by Dey consisting of 20 mg of cromolyn sodium per 2 ml and packaged in a 2 ml plastic vial with a twist-off top, Atrovent(copyright) ipratropium bromide inhalational solution, 0.02% marketed by Boehringer Ingelheim and packaged in a 2.5 ml plastic vial with a twist-off top, Mucosil(trademark) acetyl cysteine 10% and 20% solutions marketed by Dey in 4 to 100 ml vials, metaproterenol sulfate inhalation 0.4% and 0.6% solutions marketed by Dey as 2.5 mL vials, Alupent(copyright) metaproterenol 5% inhalational solutions marketed by Boehringer Ingelheim and in 10 and 30 ml bottles with a calibrated dropper, Xopenex(trademark) Inhalation Solution consisting of 0.63 or 1.25 mg of lavalbuterol HCl in a single-dose, low density polyethylene vial, and marketed by Sepracor, sterile water for inhalation, USP, and sodium chloride inhalation solution, USP in concentrations ranging from 0.45% to 10% provided in 3 to 15 ml vials by Dey. This is not meant to be an exhaustive list and it is anticipated that additional liquid medications for continuous nebulization will come to the marketplace.
The term xe2x80x9cliquidxe2x80x9d as used in the present specification is meant to relate to its ordinary dictionary meaning which pertains to a material having a flowing or fluid quality, and to relate to medicinal agents in the form of solutions, mixtures, suspensions, and the like which, at the time of use, are fluid in nature, can be transferred by pouring or flowing into a continuous nebulizer apparatus, and can be continuously nebulized. The aforementioned examples of these liquids also relate to particular containers which may be used to contain the liquid agents in a manner such that they may be dispensed by the user into a continuous nebulizer apparatus. The phrase xe2x80x9cvial with a twist-off topxe2x80x9d is meant to denote a single-dose container containing liquid and which is opened by twisting, tearing, snapping, or otherwise mechanically removing a portion of the container wall to expose its contents, which can then be poured into a nebulizer apparatus. Such single-dose containers are well known in the art and may be referred to in common usage as vials, pouches, bottles, or by a trade name. Such containers are typically uniform in material, contain the medicinal liquid within a bubble in the material, and are formed with a weakened, thin, or scored area in the wall of the bubble where they may be opened.
The term xe2x80x9cbottle with a calibrated dropperxe2x80x9d refers to a bottle which is larger than a single-dose vial, typically of plastic or glass, and which can contain multiple doses of liquid medications for nebulization. Such bottles can be re-closed. A calibrated dropper allows the user to dispense the liquid to be nebulized into a continuous nebulizer apparatus.
Liquid medications for continuous nebulization may be used alone, but it is often desired to use them in combination. It is recognized that continuous nebulization is typically utilized by infants, young children, and debilitated individuals because of the inability of such individuals to coordinate their inhalational effort or are otherwise unable to master the technique of using hand-held metered dose inhalers. It is not uncommon for a young mother to be required to administer continuous inhalation treatments to an infant or young child suffering from a respiratory disease, such as asthma, many times per day, and such treatments are typically required over periods of months to years. Each treatment may consist of a multiplicity of agents and the agents may be required to be given separately or mixed together. The order of administration may be important, for example, administering a fast-acting bronchodilator to open the airways before administering other agents, so as to allow better penetration of the subsequent agent(s). In some instances, the same combinations of medication may be given at each treatment time, and in others, the medications at each treatment time may vary, for example, different agents for morning and evening.
Multiple and variously packaged medicinal continuous nebulization liquids may be prescribed for use in conjunction with each other to comprise a treatment regimen for respiratory diseases. In the current state of the art, each agent is separately packaged, separately prescribed, and separately instructed. It is noteworthy that the amount of each liquid and frequency of use may vary with each medication. An important consideration of the present invention is that the medications, as they are presently dispensed, contain neither teaching nor instruction to coordinate the use of one agent with another, although such medications are often used together as a regimen. Moreover, in some instances it is required to employ a diluent to properly prepare a concentrated solution for nebulization, particularly in the case of medications that are packaged in multidose bottles, such as albuterol 0.5%. It is perceived that the present requirement for separately prescribed, separately acquired, and separately instructed continuous nebulization medications introduces a significant source of inconvenience, disorganization, potential for confusion and error for a particularly vulnerable sector of caregivers and recipients, which the present invention seeks to remedy.
The asthma death rate has notably increased in the United States in recent years, in part attributable to lack of patient compliance with multiple medications regimens. There is clearly a need for a method of reducing medication error and for enhancing therapeutic compliance with continuously nebulized topical respiratory regimens.
It is well known that simplicity and ease of use benefit medication compliance, and effective therapy. A device to organize, simplify, and thereby enhance ease of use and compliance with multiple liquid medications for continuous nebulization, has been overlooked. No pharmaceutically formulated device that combines such nebulization liquids together into a single organized package regimen with clear indicia and coordinated instruction is presently commercially marketed or available to a user. It is therefore the object of the present invention to provide these devices and methods.
In accordance with the foregoing objectives, the present invention comprises a device for reducing medication error and enhancing therapeutic compliance with the combined use of inhalational solutions for treating respiratory disorders such as bronchitis, emphysema, asthma, cystic fibrosis, and bronciectasis, comprising: (a) at least two liquid medications for continuous nebulization to the respiratory tract in separate non-pressurized containers; (b) indicia for distinguishing the liquids; (c) instructions for coordinating use of the liquids together; and (d) a unifying container. The present invention may optionally include an apparatus for measuring outcomes of using the nebulized liquids. The present invention further comprises a method to enhance convenience, reduce medication error and enhance compliance with combined liquid medications for continuous nebulization for treatment of respiratory tract disorders.